Skeletal MuscleNAD-fluxNCT04905446
Measurement of NAD+ Synthesis in Human Skeletal Muscle
A study testing Deuterated nicotinamide (D4-NAM) IV infusion, Skeletal muscle biopsy and Skin tissue biopsy in people with Skeletal Muscle, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The key objective of this pilot research study is to dose human volunteers with a heavy (non-radioactive) isotope derivative of nicotinamide to detect NAD synthesis in human skeletal muscle. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle
- What is being tested?
- Deuterated nicotinamide (D4-NAM) IV infusion, Skeletal muscle biopsy and Skin tissue biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects who, at the time of screening are between the ages of 21 to 40 years of age, inclusive.
- BMI between 20-30 kg/m2 at the screening visit (SV)
- Understands the procedures and agrees to participate by giving written informed consent
- Willing and able to comply with the scheduled study day and other study procedures
Who cannot join
- Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- History of type 1 or type 2 diabetes mellitus, including pre-diabetes (HbA1c > 5.7)
- History of any antihyperglycemic agent (e.g., insulin)
- Currently taking medications that can alter glucose homeostasis (e.g., steroids, glucocorticoids, nicotinic acid) or skeletal muscle metabolism
- History of taking Tru Niagen, Basis (or any other NR-containing NAD+ booster) or niacin supplements.
- Any bleeding disorders
Show all 22Show fewer
- Currently taking any aspirin (ASA) (including baby ASA) or NSAIDs (ibuprofen, naproxen, etc.) that cannot be safely stopped throughout the study. There is a recommended hold on NSAIDs and/or ASA for at least 2 days prior to biopsy, although not exclusionary
- Presence of bruising in lower extremities
- Any major surgery within the past 3 months
- Any acute or chronic infections
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or allergic diseases, but excluding untreated, asymptomatic, seasonal allergies at the time of intervention.
- Previous difficulty with lidocaine or other local anesthetic agents
- Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
- Use of tobacco or nicotine-containing products within the last 12 months.
- Chronic kidney disease with GFR of < 60
- Anemia (hemoglobin <12 g/dl) during screening
- History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Liver function testing for ALT or AST greater than or equal to 2 times the upper limit of normal
- Participation in studies involving investigational drug(s) within 30 days prior to Screening visit
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days Labs may be repeated at the discretion of the PI, MI or Sub-investigators (Sub-I).
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
The key objective of this pilot research study is to dose human volunteers with a heavy (non-radioactive) isotope derivative of nicotinamide to detect NAD synthesis in human skeletal muscle. The ultimate goal is to examine the impact of lifestyle choices, aging, nutraceuticals, and drugs on the rate of NAD synthesis in human subjects.
- Conditions
- Skeletal Muscle
- Being tested
- Deuterated nicotinamide (D4-NAM) IV infusion, Skeletal muscle biopsy, Skin tissue biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterated nicotinamide (D4-NAM) IV infusionOther
Nicotinamide adenine dinucleotide (NAD) is a vitally important substance that is found in all cells of the body. D4-NAM (in normal saline) will be infused via an indwelling catheter.The IV infusion will continue for 8 hrs.
Skeletal muscle biopsyProcedure or surgery
Participants will have a muscle biopsy performed on the muscle in the thigh. We will collect a small sample of blood before the biopsy. This procedure is used to sample muscle cells from the right or left leg Vastus Lateralis (thigh) muscle.
Skin tissue biopsyProcedure or surgery
This procedure is used to sample skin tissue from the upper thigh via a punch biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy male subjects | Other | Not described Receives: Other: Deuterated nicotinamide (D4-NAM) IV infusion; Procedure: Skeletal muscle biopsy; Procedure: Skin tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start10 Sep 2021
- Primary completion14 Jun 2022
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Gardell, PhD, Principal investigator, Senior Investigator, Translational Research Institute, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905446
- Sponsor's protocol ID
- 1581811
- Acronym
- NAD-flux
- Status last verified
- Mar 2025
- First submitted
- 21 May 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of NAD+ Synthesis in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT04905446
- Acronym / sponsor ID
- NAD-flux / 1581811
- Conditions
- Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The key objective of this pilot research study is to dose human volunteers with a heavy (non-radioactive) isotope derivative of nicotinamide to detect NAD synthesis in human skeletal muscle. The ultimate goal is to examine the impact of lifestyle choices, aging, nutraceuticals, and drugs on the rate of NAD synthesis in human subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male subjects | Other | Other: Deuterated nicotinamide (D4-NAM) IV infusion, Procedure: Skeletal muscle biopsy, Procedure: Skin tissue biopsy |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects who, at the time of screening are between the ages of 21 to 40 years of age, inclusive.
- BMI between 20-30 kg/m2 at the screening visit (SV)
- Understands the procedures and agrees to participate by giving written informed consent
- Willing and able to comply with the scheduled study day and other study procedures
Key exclusion criteria (22 listed)
- Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- History of type 1 or type 2 diabetes mellitus, including pre-diabetes (HbA1c > 5.7)
- History of any antihyperglycemic agent (e.g., insulin)
- Currently taking medications that can alter glucose homeostasis (e.g., steroids, glucocorticoids, nicotinic acid) or skeletal muscle metabolism
- History of taking Tru Niagen, Basis (or any other NR-containing NAD+ booster) or niacin supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterated nicotinamide (D4-NAM) IV infusionNicotinamide adenine dinucleotide (NAD) is a vitally important substance that is found in all cells of the body. D4-NAM (in normal saline) will be infused via an indwelling catheter.The IV infusion will continue for 8 hrs. | Other | Healthy male subjects |
| Skeletal muscle biopsyParticipants will have a muscle biopsy performed on the muscle in the thigh. We will collect a small sample of blood before the biopsy. This procedure is used to sample muscle cells from the right or left leg Vastus Lateralis (thigh) muscle. | Procedure or surgery | Healthy male subjects |
| Skin tissue biopsyThis procedure is used to sample skin tissue from the upper thigh via a punch biopsy. | Procedure or surgery | Healthy male subjects |
Primary outcome
Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Gardell, PhD principal investigator
Senior Investigator, Translational Research Institute, AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deuterated nicotinamide (D4-NAM) IV infusion, Skeletal muscle biopsy and Skin tissue biopsy in people with Skeletal Muscle, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.